Media: Press Releases

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Noven Pharmaceuticals, Inc., a wholly-owned subsidiary of Hisamitsu Pharmaceutical
Co., Inc., today announced that it has completed the Phase 3 clinical
development program evaluating low-dose mesylate salt of paroxetine (LDMP)
for the treatment of vasomotor symptoms (VMS) associated with menopause
(hot flashes). The Phase 3 clinical program was comprised of two studies
involving an aggregate of 1,180 subjects from more than 130 centers across
the U.S.

The first Phase 3 study was a 24 week, multi-center, double-blind,
randomized, placebo-controlled efficacy and safety study of LDMP for
the treatment of menopausal VMS. The primary outcome measures were mean
changes in frequency and severity of moderate-to-severe hot flashes from
baseline to the fourth and twelfth weeks of the study, as well as maintenance
of therapeutic effect at week 24. As announced in December 2011, all
primary outcome measures in the first study were achieved with statistical
significance.

The second Phase 3 study, which received a Special Protocol
Assessment (SPA) by the U.S. Food & Drug Administration (FDA), was
completed in February 2012. It was a 12 week, multi-center, double-blind,
randomized, placebo-controlled efficacy and safety study of LDMP for
menopausal VMS. The primary outcome measures were mean changes in frequency
and severity of moderate-to-severe hot flashes from baseline to the fourth
and twelfth weeks of the study. All primary outcome measures in the second
study were achieved with statistical significance, except for severity
at week twelve, which did not reach statistical significance.

In accordance
with the SPA, the second study included a responder analysis necessary
to demonstrate the clinical meaningfulness of subject response. The first
study also included a responder analysis, and in both studies the responder
analysis endpoints were achieved with statistical significance. The most
frequent adverse events observed in the Phase 3 program were nasopharyngitis,
upper respiratory tract infection, diarrhea, headache, nausea and fatigue.

“Our
LDMP Phase 3 program has generated what we consider to be a robust clinical
data set that will form the basis of our planned New Drug Application
(NDA) for this developmental low-dose non-hormonal option to treat menopausal
VMS,” said Joel S. Lippman, M.D., Noven’s Executive Vice President –
Product Development and Chief Medical Officer. “As next steps, we are
scheduling a pre-NDA meeting with the FDA, and expect to submit our NDA
for LDMP in 2012.” Noven plans to publish additional details on the LDMP
clinical development program at future medical/scientific forums.

About Noven
Noven Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged
in the research, development, manufacturing, marketing and sale of
prescription pharmaceutical products. Noven is committed to developing
and offering products and technologies that meaningfully benefit patients,
its customers and its industry partners. Noven is a stand-alone operating
subsidiary of Japan-based Hisamitsu Pharmaceutical Co., Inc., and serves
as Hisamitsu’s U.S. growth platform in prescription pharmaceuticals.
For more information about Noven, visit www.noven.com. For information about Hisamitsu, visit www.global.hisamitsu.